Diagnostic Study In Patients Receiving Treatment For Brain Tumors - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020293

Purpose

RATIONALE: New diagnostic procedures such as 1H-nuclear magnetic resonance spectroscopic imaging may be more effective than MRI in evaluating side effects of cancer therapy in patients who are receiving treatment for tumors.

PURPOSE: Diagnostic trial using 1H-nuclear magnetic resonance spectroscopic imaging and MRI of the brain in patients who are receiving cancer therapy for tumors.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Drug: gadopentetate dimeglumine Procedure: magnetic resonance spectroscopic imaging

MedlinePlus related topics: Cancer MRI Scans

Drug Information available for: Gadolinium dtpa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	1H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2000

Detailed Description:

OBJECTIVES:

Determine the specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using 1H-nuclear magnetic resonance spectroscopic imaging in patients with cancer.

OUTLINE: Patients undergo 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI), followed by gadopentetate dimeglumine IV, followed by conventional magnetic resonance imaging (MRI) prior to anticancer therapy, immediately after the first course of therapy, prior to subsequent courses of therapy, and/or after completion of all therapy. Patients may also undergo age-appropriate neuropsychological testing within 1 week of 1H-NMRSI and conventional-contrast MRI.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 2 years.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of brain tumor OR
Receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiotherapy OR
Documented or suspected clinical neurotoxicity presumed to be caused by anticancer treatment
No preexisting neurologic or genetic conditions unrelated to tumor

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant
Negative pregnancy test
No braces or permanent retainers
No metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants, or ferrous surgical clips
No physical or psychological factor that would preclude imaging studies
No history of severe reaction to gadolinium

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Concurrent immunotherapy allowed

Chemotherapy:

See Disease Characteristics
Concurrent chemotherapy allowed

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
Concurrent radiotherapy allowed

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020293

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Katherine Warren, MD

NCI - Pediatric Oncology Branch

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000068229, NCI-99-C-0088
Study First Received:	July 11, 2001
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00020293
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified childhood solid tumor, protocol specific
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Brain Neoplasms

ClinicalTrials.gov processed this record on January 14, 2009